Scan report is in. After 3 months the masses are stable within a millimeter of the previous scan. This is a good result. We may post more after we get more details, but we wanted to share the good news as quick as possible.
Ursula and I are in the same business as the people who are working to save her life in NY. We have some things in common. We speak the same language, for the most part. But there are times where its hard to fathom that we exist in the same universe.
Ursula has an appointment at the clinic this upcoming Monday. 4 days prior to that appointment we got a phone call telling us that our account had run out of funds and we needed to send another significant sum of money by Friday, or they would cancel the appointment. If we couldn’t pay, they would discharge us from the clinic.
If you don’t remember, when this trial started about 18 months ago, they asked us to pay up front a large deposit, one that was intended to cover the entire 24 months of the trial. It was supposed to be used for the cost of doctor’s visits, lab tests, and diagnostic imaging, all of which was set out in a schedule based on the trial protocol. The total cost for the trial should have been relatively straightforward to estimate. In spite of the fact that we haven’t done anything out of the ordinary, though, we have run out of funds from that initial deposit.
My first instinct was to go back and look at the billings to see if they had made an error, or if we were being overcharged for something and in that moment it hit me:
There would never be any recourse because they can charge us whatever they want.
If they decided that doctors visits should be worth 25% more this year, am I going to tell them they are gouging us? If they say they need an additional blood test because its necessary, could we really say no and remain in the trial? But the price for that blood test is set by that hospital. And the profit that is made from that blood test is made by that hospital, which employs the doctor that ordered it. This conflict of interest never ceased to amaze me, and while it annoyed me on an intellectual level before, it landed much harder this week.
The people who conduct business for the hospital are not the doctors. They are administrators. People who are charged with the task of making sure that everything gets payed for. And the feeling that we got from them was very cold. If we didn’t have the money, we wouldn’t continue. It was as simple as that.
It has to be said that while this is uncomfortable for us, there must be countless others who are faced with this situation every day. And for them, they are going bankrupt, or worse, they are going to die because they can’t access the help any more. In so many ways we are lucky, but the most important of these is that we don’t have to make choices between poverty and wellness.
As I try to mount a angry response to a health system that literally ruins lives while it saves them, I can hear the voices of those defending the other side of the argument: if this system didn’t exist, there would be no nivolumab saving Ursula’s life. Is that true? Are the medicines and the research driving them only available because we allow hospital systems to decide the going rate for saving a life? I suppose that might be true. This drug wasn’t developed in a public system, it was developed in the United States. By American companies. Without them, my wife wouldn’t be alive for me to be bitching about the rates they charge.
In my heart, there is a better way. A way to reward the doctors and hospitals that do this good work, but that prevents the gross conflicts of interest that exist within the system. For this reason and many others, I will never work in the US. I am proud to participate in a public system that serves the sick as its only priority. In the same breath, though, I am angry at a system where I have no hope for fair treatment and so grateful to have the help that it has provided. So messy and so bittersweet.
We feel a little bit like detectives piecing a puzzle together. Ursula came home from New York after speaking to the principal investigator of the study and left feeling like there was no imminent risk of her needing to leave the trial. This, it goes without saying, is good news. But before she got treatment, Ursula’s leg was starting to bother her. The leg where she had the surgery was hurting from the hip to the ankle. We talked about it that night, and we feared that it might have been a blood clot, precipitated by all the flying she was doing. By the time she got back to Calgary, the rash and the pain were both worse. She went to the Foothills ER on Friday, and they confirmed there was no blood clot. But they said something that has been on my mind ever since. They said it looked like a vasculitis. A vasculitis is an inflammation of the arteries and veins. It can happen anywhere, but it’s usually an autoimmune reaction. Your body’s immune system responding to the proteins it should be ignoring. Which sets me thinking. The episcleritis in Ursula’s eye that we have been dealing with may have been the very same thing. Now, her leg is reacting. There have been other symptoms too. Flu-like symptoms that have been intermittent. Unexplained fatigue fading in and out. What I believe about this now is that there has been Nivolumab- induced inflammation going on throughout the trial and it’s showing itself in different ways. The vitiligo, the episcleritis, and now this vasculitis. I’m not sure if this is anything worth worrying about. At worst, these things interrupt treatment when they pop up. As far as anti-cancer side-effects go, as anyone who has been on conventional chemotherapy will tell you, this is small potatoes. But it is an interesting thought that this has been with us in various forms, from beginning to end. And it may be the very thing that is causing the treatment to be so effective. Our bottom line today is that there is some retrospective clarity on the ups and downs of the trial, but that overall, things are still positive. We will continue to update more often as we get more information and we learn more about it.
For all the fretting that the last few weeks have brought, Ursula is sitting in a treatment room in Memorial Sloan Kettering, her eye returned to normal, receiving treatment. We will provide more details about the conversation about her staying in the trial, but wanted to let everyone know the good news that we are still actively being treated.
This is just a quick note to keep everyone in the loop. We are in a holding pattern with the trial. Ursula flew to the appointment this week with an intention to sort out whether the eye inflammation was a reason to stop the trial and hopefully to start treatment again. She has missed 2 of the last 3 treatments due to inflammatory reasons, and we are certainly a little anxious to know what the future holds.
The short version of the story is that in spite of the episcleritis being 95% resolved, seeing an ophthalmologist in NY, and all of the doctors seeming ok with the plan to resume treatment, treatment was withheld again this week. The reason being that inflammation of this sort is against the protocol and can’t be offered. For the record, the seemingly arbitrary rules associated with trials are incredibly frustrating. Though, we have benefitted from the rules being bent to allow us in (we are more than the 2 hour commute away from the centre), so it is hard to complain too much.
We also are no further along with what this means in the trial. It felt like we were very close to getting treatment this time, but it still didn’t happen. But they also didn’t say that the trial was over. This means we wait for the next appointment in 2 weeks to find out more. We will fill you in when we know more.
hi there –
Lauren and I have been like ships passing these last few days (kids, New York, etc…) — so I didn’t realize that he was going to post today! I will just add a few details.
A few more details: it’s not a conjunctivitis, but an episcleritis. (Different part of the eye. The episclera is between the conjunctiva and the deeper sclera).
I had the same issue in my other eye a couple of months ago — and missed a treatment because of it — but it resolved quickly with some steroid drops. I saw a Calgary opthalmologist at the time, who did a full examination. At the time, I was worried that it might be from the melanoma itself, as there are case reports of the eye as a site of metastasis. But that would have been obvious on slit lamp exam, and there was no melanoma there. It was just an inflammatory response in the episclera, and presumably that’s happening again.
My immune system is juiced up from the Nivolumab, and so inflammatory responses (any or all of the ‘itis’-es) could be expected. I haven’t had any side effects at all since the Colitis Misadventure of 2013 — and that was from the other drug (Yervoy). I’ve heard informally that joint inflammation is more common later on in Nivolumab treatment; but I haven’t had a trace of that.
Anyway. Apparently, the study protocol cautions against proceeding with Nivolumab in the face of any eye inflammation.
I roll my eyes at that a little bit (the red one and the other one) — it’s not as though it’s an arrhythmia! — but I don’t write study protocols. (What’s the plural of protocol? Protocol? Protocols?)
If this were week 2 of the two-year trial, or if there was no way to access the drug outside a clinical trial, then I would be scared.
As things stand, I’m reasonably content with whatever way this goes. (The choice is Dr. Wolchok’s; the principal investigator). This drug has gotten me well, but it’s not clear that ongoing doses are what keep me well at this point. Theoretically, my own immune system should be doing that on its own now. If my immune system stops keeping the melanoma in check, then we can re-challenge with the medication, outside the confines of the study protocol.
I will likely hear about it next visit (Jan 20). My guess is that they’ll stop the drug, even if the inflammation has resolved. They are a cautious group. But we’ll see.
Lastly, a note about the potential financial outlay for an FDA-approved drug that is not yet approved in Canada. When I started this trial, Nivolumab had not yet been approved by the FDA, which is the regulatory body in the US. It has now been approved and is available there. So is another anti-PD-1 agent developed by rival drug company Merck.
Health Canada isn’t contributing to my current MSKCC medical costs because I’m in a clinical trial, and Health Canada doesn’t cover international trial costs (how could they? They’d go bankrupt). But they would actually cover a drug that I needed but that I had to go elsewhere to get, as long as there is evidence to support it. I would rather stay in the trial until the 2-year mark (August), but bizarrely, leaving the trial would probably save us money. So nobody freak out about our financial situation, please.
That’s just a gratuitous shot of Ben, who disagrees with his winter hat.
Lots of love,
Ursula is just back from her appointment in New York, having seen the oncologist, but she did not receive treatment. Her eye, which has been an issue in the past, is an issue again. She has an inflammatory process in the conjunctiva (I think – it could be another part of the anatomy, as well). This had been an annoyance in the past which led to interruptions in treatment, but today things became more serious. On Wednesday, Ursula were told that If the eye problem continued to persist, she would not be able to continue in the study.
To give you some perspective on where things are at with us, we are very lucky. We have had a tremendous response with a medication that didn’t exist a few years ago and has allowed Ursula to return to her regular life. We are so grateful for the prayers and the kindness of everyone who sends us well wishes, and Ursula has worked very hard to change her lifestyle (which wasn’t unhealthy to begin with) to improve her health overall, but we all believe in our heart of hearts that the thing that has made the difference is that medication. The prospect of coming off of it is daunting.
We knew we were going to face this moment eventually. We were going to be faced with it this summer, in fact. The trial is scheduled to end in six months. And, to be clear, no one knows if she even still needs to be on the medication. These trials are built to learn about the medication for this very reason. The masses have shrunk dramatically. They have been stable for 6 months. There are no new masses. If this wasn’t a trial, any reasonable doctor would be stopping this medication, and probably would have stopped it a long time ago. So, if wee have to stop, we are not stopping at a point when everything is still up in the air. We are stopping at a point which is pretty reasonable, in fact.
What do we do off of the medication? The cancer centre has been very clear that they will follow her for the rest of her life, if we want. And they have said also that access to the medication in the US would be available to her because she had been a responder, and she would be very likely to respond again, if she needed it. It would be so much better if we could access it in Canada somewhere, but that seems not in the cards for the near future. It seems like if it came back, we would be back in NY. And the challenge there is that the cost of the medication may be the deal-breaker. The trial had covered the cost medication up until this point, but that would no longer be the case. We are looking to see what the cost is, and if we could find a way to get it released compassionately, or covered by Alberta Health Services. Of course, with the tumours in remission, no one is going to approve the treatment just in case. So we have that legwork to do if and when it were to come back.
Overall, it has been as anxious a day as we have had in a full year. Our next steps are to send Ursula back to NY in 2 weeks and re-evaluate the eye. We are also going to find an ophthomologist here to help us nail down the diagnosis. There will be more to report in 2 weeks time, though. And perhaps more work to be done then. For today, we are in a wait-and-see mode that is uneasy, but manageable.